Cardiac SurgeryNCT03905213
Prevention of Surgical Wound Infection
A study testing dressing MEPORE, dressing MEPILEX and dressing PICCO in people with Cardiac Surgery, run by Maria Jesus Perez.
Trial summary
To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- dressing MEPORE, dressing MEPILEX and dressing PICCO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 28 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled to cardiac surgery.
- signed informed consent form
Who cannot join
- hypersensibility to dressings
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of the Use of Three Dressings in the Prevention of Surgical Wound Infection in Patients Undergoing Mayor Cardiac Surgery: a Clinical Prospective and Randomized Study
To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery
Read the detailed description
It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.
- Conditions
- Cardiac Surgery
- Being tested
- dressing MEPORE, dressing MEPILEX, dressing PICCO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dressing MEPOREDevice
assignation to three different authorised and on label dressing: conventional dressing (MEPORE)
dressing MEPILEXDevice
assignation to three different authorised and on label dressing: absorbent(MEPILEX)
dressing PICCODevice
assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)
| Study group | Role | What they receive |
|---|---|---|
| conventional gauze | Active comparator | Device is a conventional gauze and the change will be to the day 2 and 4 of surgery Receives: Device: dressing MEPORE |
| polyurethane dressing | Experimental | Device is a polyurethane dressing and the change will be to the day 7 of surgery Receives: Device: dressing MEPILEX |
| vacuum therapy dressing | Experimental | Device is a vacuum therapy dressing and the change will be to the day 7 of surgery Receives: Device: dressing PICCO |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of surgical wound infection
surgical wound infection measured as number of patients suffering surgical wound infection during the study period
Measured: surgery date up to 6 months
Secondary outcomes (3)
hospital stay
days at hospital
Measured: from hospitalization until an average of 1 year
antimicrobial consumption
defined dose of antimicrobial agents during hospital stay
Measured: from surgery date until an average of 1 year
dressing consumption cost
number of dressing and its cost
Measured: from surgery date until an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Sep 2019 (estimated)
- Primary completion28 Aug 2021 (estimated)
- Study completion28 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized in three groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Jesus Perez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Maria Jesus Perez, Hospital General Universitario Gregorio Marañon
- Investigators
- Maria Jesus Perez Granda, PhD, Principal investigator, Gregorio Marañón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905213
- Sponsor's protocol ID
- MICRO.HGUGM.2018-008
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Granda MJ, Cuerpo G, Barrio JM, Valerio M, Munoz P, Pinto AG, Valencia DE, Vicario FS, Bouza E; Cardiovascular Infection Study Group. A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery. Sci Rep. 2025 Jun 6;15(1):19960. doi: 10.1038/s41598-025-02533-7.
PubMed 40481025
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Three Dressings in the Prevention of Surgical Wound Infection in Patients Undergoing Mayor Cardiac Surgery: a Clinical Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT03905213
- Acronym / sponsor ID
- MICRO.HGUGM.2018-008
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Maria Jesus PerezUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 28 Aug 2021 (estimated)
- Study completion
- 28 Aug 2021 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery
Detailed description
It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized in three groups
| Arm | Type | Receives |
|---|---|---|
| conventional gauze | Active comparator | Device: dressing MEPOREDevice is a conventional gauze and the change will be to the day 2 and 4 of surgery |
| polyurethane dressing | Experimental | Device: dressing MEPILEXDevice is a polyurethane dressing and the change will be to the day 7 of surgery |
| vacuum therapy dressing | Experimental | Device: dressing PICCODevice is a vacuum therapy dressing and the change will be to the day 7 of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient scheduled to cardiac surgery.
- signed informed consent form
Key exclusion criteria (1 listed)
- hypersensibility to dressings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dressing MEPOREassignation to three different authorised and on label dressing: conventional dressing (MEPORE) | Device | conventional gauze |
| dressing MEPILEXassignation to three different authorised and on label dressing: absorbent(MEPILEX) | Device | polyurethane dressing |
| dressing PICCOassignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO) | Device | vacuum therapy dressing |
Primary outcome
prevention of surgical wound infection
Time frame: surgery date up to 6 months
surgical wound infection measured as number of patients suffering surgical wound infection during the study period
3 secondary outcomes
hospital stay
Time frame: from hospitalization until an average of 1 year
antimicrobial consumption
Time frame: from surgery date until an average of 1 year
dressing consumption cost
Time frame: from surgery date until an average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Derived from this study: PubMed 40481025Perez-Granda MJ, Cuerpo G, Barrio JM, Valerio M, Munoz P, Pinto AG, Valencia DE, Vicario FS, Bouza E; Cardiovascular Infection Study Group. A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery. Sci Rep. 2025 Jun 6;15(1):19960. doi: 10.1038/s41598-025-02533-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Jesus Perez Granda, PhD principal investigator
Gregorio Marañón Hospital
Questions about this trial
What is this clinical trial studying?
A study testing dressing MEPORE, dressing MEPILEX and dressing PICCO in people with Cardiac Surgery, run by Maria Jesus Perez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Jesus Perez Granda, PhD (+34618355299, massus@hotmail.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of surgical wound infection (time frame: surgery date up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.